New drug development is Sunday drive, especially for startups. There can be costly mistakes and unanticipated roadblocks that pop up when you least expect it. Learn how to steer clear of hazards, what to do and who to talk to.

Because there are potential but invisible risks inherent in labeling artwork documents of life science companies that can’t be detected through manual proofreading, it’s important to be thorough and to know the tricks to detect and prevent these snags from causing unnecessary delays in the manufacturing process.

One of the major technological trends beginning to impact the pharmaceutical industry is artificial intelligence (AI). Analysts say it isn’t a matter of if but when AI will become a game-changer for pharma companies, particularly when it comes to slashing the time and costs involved with drug discovery. Find out what your company can do to best plan for AI’s anticipated revolutionary impact on drug development.

A look at how how global mandates for implementing mass serialization within supply chain management are coming to fruition in U.S. and European markets, just to name a couple, and how the use of technology can help supply chain managers get a better handle on this task through automated, real-time visibility.

France and Europe are witnessing an explosion of life science innovation from new startups. But what separates the winners from the losers? Learn how to successfully overcome regulatory barriers and get your product to market quicker.

Pharmaceutical companies continuing the trend of mergers, acquisition and partnerships is creating challenges, opportunities and redundancies for supplier management. To meet these changing needs, it’s imperative that managers conduct supplier evaluation and rationalization processes and emphasize “good supply practices.” Learn some of these best practices and how to adapt them to your company.

The second part of a two-part blog post that examines the importance of the emerging technology of artificial intelligence and the potential is has to bring about a massive shift in quality management for pharma and medical device manufacturers.
Xavier Health takes a closer look on how to prepare and assess the readiness of your company to implement AI.

FDA officials believe that artificial intelligence (AI) has the potential to bring about a step change in quality management in the pharma and medical device industries. Xavier Health has assembled a team of multidisciplinary experts to take a closer at the possibilities and roadblocks AI presents to quality management in both industries. Part 1 of a two-part series.

Venture capitalists have pumped $2.8 billion into biotechnology startups in the first two months of this year alone. This means two things if you’re a startup. First, expect fierce competition because a huge capital pool attracts the very best in the industry. Second, this kind of investor confidence requires that you hit the ground running.

Economic, technological, policy and scientific changes occur so frequently in the hypercompetitive pharmaceutical and biologics sectors that only the most versatile and far-sighted companies can thrive. Get the inside scoop on the top five clinical trends experts believe will be the difference between success or failure for pharma/bio organizations.

Australasia is quickly becoming a hotbed for life sector manufacturers including pharmaceutial and medical device companies from around the globe seeking regulatory approval for their products and other opportunities. Find out why.

Is the U.S. FDA about to approve the first cannabis-derived drug to win federal approval? In a recent FDA Advisory Committee meeting, a teenage boy addressed committee members. Sam, an epilepsy patient, was the first U.S. citizen to try Epidiolex, a cannabis-derived drug. Read about the future of medical marijuana.

Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The second part of a two-part series.

Experts at the FDA/Xavier PharmLink conference at Xavier University in March 2018 presented and analyzed the FDA's top 10 drug GMP inspection citations for FY2017 during a panel discussion. The first part of a two-part series.

As technology advances, human error in manufacturing becomes more and more visible every day. Human error is responsible for more than 80 percent of failures and defects. Sadly, little is known about the nature of these events mainly because the quest for answers ends where human error investigations should begin. This situation has become very evident to regulators and GMP enforcement agencies are being more critical of the approach, result, and effectiveness of corrective and preventive actions or CAPAs when dealing with human performance issues. In order to successfully achieve this goal, we have to understand how to improve the way we deal with these types of situations.

Prevent your supply chain from becoming neglected by strategically designing each link in the chain. The key to a successful supply chain isn't focusing on the endpoint but rather bolstering each location along the way.

Get up to speed on key takeaways from what are expected to be some of the most tranformational trends to affect the pharmaceutical industry in 2018. And for further analysis of some of the top trends in pharmaceuticals this year, check out the associated white paper.

8 March, 2018
by Christine Simmon, Executive Director of the Biosimilars Council, a division of the Association for Accessible Medicines

It is a difficult irony that even as medical breakthroughs and new life-saving and life-extending treatments bring hope to patients and families across the country, it also is getting harder for many to afford these critical medicines. The rapidly rising cost of brand-name biologic medicines, which comprise the vast majority of new therapies in the pipeline, mean they are often inaccessible for America’s patients.

It’s said that change is never easy. But in the pharmaceutical industry, flexibility, and adaptability are part and parcel of successfully delivering the safest, highest quality products to a global market.